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Colombia Medical Device Registration

Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) approval timelines and requirements

1-2 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

Colombia Registration Holder (CRH)

Colombia Medical Device Registration Overview

Colombia medical device registration through INVIMA typically takes 1-2 months for Class I devices. The official INVIMA target is 0.5-1 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Colombia uses a 4-class (I, IIa, IIb, III) risk-based classification system. Foreign manufacturers must appoint a Colombia Registration Holder (CRH) to register devices in Colombia. Registration is valid for 10 years.

Registration Timeline by Device Class

Colombia uses a 4-class (I, IIa, IIb, III) risk-based classification system.

Class I

Notification (NSO)

Low Risk

Official

0.5-1 months

Realistic

1-2 months

• Notification-based, minimal review

Class IIa

Registration (NSO)

Medium Risk

Official

2-4 months

Realistic

3-6 months

With Prior Approval

2-3 months

Accelerated with: FDA 510(k), EU CE Mark, Health Canada

• Reliance pathway available for recognized approvals

GMP/QMS Required

Class IIb

Registration (RSO)

High Risk

Official

4-8 months

Realistic

6-12 months

With Prior Approval

4-6 months

Accelerated with: FDA 510(k), EU CE Mark, Health Canada

• Technical documentation review required

GMP/QMS Required

Class III

Full Registration (RSO)

Highest Risk

Official

6-12 months

Realistic

9-18 months

With Prior Approval

6-10 months

Accelerated with: FDA PMA, EU CE Mark Class III, Health Canada

• Clinical evidence mandatory

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

Recognition of Prior Approval

Expedited pathway for FDA, EU, Health Canada, Japan, Australia, Brazil approved devices

30-50% faster

Eligibility: Class IIa, IIb, III devices, Approval from recognized authority

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Colombia registration.

FDA 510(k)

Recognition pathway - expedited review

2-4 months

EU CE Mark

Recognition pathway

2-4 months

Health Canada

Recognition pathway

2-4 months

ANVISA (Brazil)

Mercosur harmonization

2-3 months

Key Requirements

Colombia Registration Holder (CRH) - mandatory for foreign manufacturers
Spanish labeling and IFU
Free Sale Certificate
GMP certificate (ISO 13485)
Technical documentation

Registration Validity:

10 years

Registration Process Flowchart

Colombia Medical Device Registration Process

Step-by-step INVIMA registration process. Total estimated timeline: 1-2 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by INVIMA. Appoint a Colombia Registration Holder (CRH).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to INVIMA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

INVIMA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

0.5-1 months

In-depth technical assessment of device safety and performance. INVIMA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, INVIMA issues Colombia market authorization certificate.

Summary: The Colombia medical device registration process through Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

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Compare With

🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇧🇷 BrazilANVISA 🇨🇦 CanadaHealth Canada

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.